Alterations in Intestinal Mucosal Barrier Visualized by Confocal Laser Endomicroscopy in Liver Cirrhosis: a Pilot Trial (AMBIC)

Dr.med. Monica Rusticeanu

Status: Terminated

Conditions: Liver Cirrhoses

Treatments: Device: Cellvisio 100 Series (fibered confocal microscopic system)

Study type: Observational

Funder types: Other

Identifiers

NCT03878563

2017-00249

Details and patient eligibility

About

Clinical trial with medical devices. A diagnostic trial conducted to find a better (less invasive) procedure for predicting the onset of spontaneous bacterial peritonitis(SBP), which is a complication of liver cirrhosis with ascites.The current recommendation for primary prophylaxis of SBP include a low protein content of the ascitic fluid or a gastrointestinal bleeding. This trial will use the CLE (confocal laser endomicroscopy) technic in order to quantify the intestinal permeability in patients with liver cirrhosis and correlate this to the onset of spontaneous bacterial peritonitis.We aim to evaluate a new diagnostic tool (the confocal laser endoscopy(CLE) technique -cellvizio- in the setting of endoscopy and defining parameters that are altered in cirrhotic patients of different severity and being at risk of developing a SBP (spontaneous bacterial peritonitis).The parameters assessed by confocal laser endomicroscopy will be correlated with the protein content in ascitic fluid and the patient will be monitored for time to occurrence of spontaneous bacterial peritonitis.

Defining a correlation between the quantified loss of intestinal integrity and i) total protein concentration in the ascitic fluid and ii) stadium of liver disease (Child class A, B or C)

Enrollment: 26 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Adult individual (>18yo) with liver cirrhosis of any cause and healthy controls undergoing elective endoscopy

Exclusion criteria

• Patients younger than < 18, older than 80 years
• Pregnant or breastfeeding women
• Known allergy to fluorescein.
• Cardiac disease
• Asthma bronchiale
• Patients with inability or unwillingness to provide blood samples or samples of ascitic fluid.
• patients unable to give informed consent
• non-resident patients
• contraindication for an endoscopic examination

Trial design

26 participants in 5 patient groups

ascites with/without SBP

Description:

Cirrhosis with ascites and existing SBP or prior SBP

Treatment:

Device: Cellvisio 100 Series (fibered confocal microscopic system)

ascites and decreased protein concentrati

Description:

Cirrhosis with ascites and decreased protein concentration \<1,5 g/d

Treatment:

Device: Cellvisio 100 Series (fibered confocal microscopic system)

ascites and normal protein concentration

Description:

Liver cirrhosis witha scites and protein concentration \>1,5 g/d

Treatment:

Device: Cellvisio 100 Series (fibered confocal microscopic system)

Liver cirrhosis without ascites

Description:

Patients with liver corrhosis without ascites

Treatment:

Device: Cellvisio 100 Series (fibered confocal microscopic system)

Healthy controls without liver cirrhosis or other pathology

Description:

Healthy pacients (without chronic disease) undergoing screening coloscopy or gastroscopy

Treatment:

Device: Cellvisio 100 Series (fibered confocal microscopic system)